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✓ Certified Professional Seller INT Medical Sheath Kit — Manifold
INT Medical Sheath Kit — Manifold
INT Medical Sheath Kit — Manifold
INT Medical Surgical & Therapeutic Equipment

INT Medical Sheath Kit — Manifold

Six components in one pack, across seventeen references and four sheath sizes.

An introducer set, a manifold, an angiography syringe, a Seldinger needle, an extension tube and a scalpel, packed together for one case. Four introducer sizes cross four tube lengths to make sixteen, and a seventeenth reference sits outside that grid.

Sections
General Instrument Sets
Categories
Surgical & Therapeutic Equipment
Condition
New
Origin
China
Seller Type
Certified Professional Seller
CE & ISO Certified
Global Shipping
Supplier: Medigear
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Across seventeen references, the INT-YX-001 series is Shanghai INT Medical Instruments' intervention accessories kit for the catheter laboratory. Each reference lists six components: an introducer set, a 3-port manifold, a 12 mL angiography syringe, an 18G Seldinger needle, an extension tube, and a 15D scalpel. Two of those six vary: the introducer set at 5F, 6F, 7F, and 8F, and the extension tube at 30, 60, 90, and 120 cm, giving a complete four-by-four grid of sixteen references. A seventeenth, INT-YX-021-01, publishes a specification identical to INT-YX-001-01. Three claims appear against the family, covering comprehensive configuration, wide adaptability and individually packaged components preventing air or fluid leakage. No figure supports any of these.

What a buyer acquires here is as much a regulatory position as a set of parts. Under UK MDR 2002, a procedure pack is not conformity assessed as one device. The assembler draws up a declaration that every component carries CE marking, that they were combined for their intended purposes, and that the work was carried out under appropriate internal control. The pack must still be registered with the MHRA before it reaches the Great Britain market. Where any component lacks CE marking or is used outside its intended purpose, the combination becomes a device in its own right and requires a full conformity assessment. Diligence therefore runs to seven documents rather than one.

The sheet withholds the numbers that decide usability. The extension tube is published only as a length. The introducer set is published as a French size, with no sheath length, guidewire specification or coating statement.

No dimensional information is published. Medigear.uk lists the INT-YX-001 series for UK business buyers. Request the pack declaration, component conformity routes, extension tube pressure rating, introducer specification, and sterility statement from the seller before ordering.

The INT-YX-001 series supports percutaneous vascular access and contrast delivery, placing it in the catheter laboratory, the interventional radiology suite, and any theatre running image-guided vascular work. The six components map onto one sequence: a skin nick with the scalpel, arterial puncture with the Seldinger needle, sheath placement from the introducer set, then contrast delivery through the syringe, the manifold and the extension tube.

The access route decides which references a service can use, and the sheet leaves that open. A radial-first laboratory works mainly at 6F, reaches for 7F on complex cases, and rarely goes beyond it, so that the 8F references may have no application there at all. A service doing femoral work uses the larger sizes routinely. Since neither the sheath outer diameter nor a wall statement is published, a radial service cannot determine from this datasheet which part of the range fits its practice.

Extension tube length maps onto room geometry rather than clinical need. The distance from the injector or the operator's hand to the sheath hub varies with table position, screen placement and whether the operator stands at the wrist or the groin, and 30 to 120 cm covers that spread. A department that standardises on one working length will use a narrow slice of the series and should say so at quotation rather than stocking all four.

Procurement runs through the usual routes. NHS Supply Chain, trust framework agreements, Integrated Care Boards and independent providers each apply their own standing financial instructions, and a procedure pack triggers a specific evidence request because the pack and its components are documented separately. The conformity documentation required by those procurement routes is issued by the manufacturer and provided by the seller.

One line item covers six components.

Ordering, receipting, stock-counting and picking happen once instead of six times. Collapsing six catalogue lines into one removes a recurring administrative cost that never appears in a unit price comparison.

The reference number encodes both variables.

French size and tube length are the only two things that change across the series, and the reference number carries both. A store clerk or a scrub practitioner can read the configuration off the label without consulting a specification, which is a small thing that matters at four in the morning.

The grid is complete.

Four introducer sizes cross four tube lengths with no gaps, so any combination a service settles on exists as a reference. A department can standardise on one square of the grid without having to special-order its preferred pairing.

Components are individually packaged.

The manufacturer states that components are packaged individually within the pack. That supports opening only what a case needs and keeps the unopened items intact, though no barrier or seal specification is published to describe how that packaging behaves.

Nothing powered, nothing to test

No component draws current. The pack sits outside portable appliance testing, outside every electrical safety scheme the provider runs, and outside the electronic waste regulations by construction. It also carries no radiation obligation of its own, despite being used in a room that does.

The waste split is predictable.

Two items leave by the sharps route,e and the rest go to the healthcare waste stream. Both are already running in any laboratory doing this work, and no component requires a separate contract or stream.

Stock control collapses to one number per configuration

A department tracks packs instead of six independent consumption rates with six reorder points. Where usage is stable, that is a simpler forecasting problem, and it removes the failure mode where five items are in stock, and the sixth is not.

An identifiable manufacturer

Shanghai INT Medical Instruments publishes a corporate structure, named subsidiaries and investor documentation on its own domain, for a procedure pack that matters more than usual, because the assembler is the party who signs the pack declaration and the party a vigilance report has to reach.

Cost is a cost per case.

One pack is consumed per procedure, so the meaningful figure is pack price multiplied by annual case volume, set against the six unit prices it displaces. Build the comparison that way from the first conversation and ask for banded pricing against volume.

Six published components

Every reference lists an introducer set, a manifold, an angiography syringe, a Seldinger needle, an extension tube and a scalpel. None is shown as optional or as sold separately.

Four introducer set sizes

The introducer set is published at 5F, 6F, 7F and 8F. No sheath length, outer diameter, wall thickness, coating statement or dilator description accompanies the French size.

Four extension tube lengths

The extension tube is published in lengths of 30, 60, 90 and 120 cm. No pressure rating, material, construction or connector type is stated.

Three-port manifold

Every reference carries a 3-port manifold. No pressure rating, stopcock handle type, rotating adapter statement or dead-space figure is published.

Twelve millilitre angiography syringe

Every reference carries a 12 mL angiography syringe. No pressure rating, control handle description or graduation interval is published.

Eighteen gauge Seldinger needle

Every reference carries an 18G Seldinger needle. No length, bevel form, hub type or wall description is published.

Fifteen-D scalpel

Every reference carries a 15D scalpel. The designation is not standard in UK usage, and no blade number, holder type or blade guard statement is published.

Seventeen published references

Sixteen references form a complete four-by-four grid of introducer size against tube length. A seventeenth, INT-YX-021-01, carries a specification identical to INT-YX-001-01 across all six published columns.

Individually packaged components

The manufacturer states that components are individually packaged, which ensures proper connections and prevents air or fluid leakage. No connector standard, leak test or pressure condition is cited in support.

Wholly passive construction

No battery, circuit or powered element appears anywhere in the pack. Nothing requires a power source, a charge state or an electrical safety record.

Extension tube pressure rating not published

The property that determines whether the tube can be used with a power injector has no figure. No psi, MPa, material, or construction statement appears anywhere.

Introducer set detail not published.

Sheath length, guidewire diameter and length, tip form, dilator description, wall thickness and coating are all absent, leaving the French size as the only published attribute.

Sterility not published

No sterility statement, sterilisation method, validation standard, packaging standard or shelf life appears for a pack whose contents enter an artery.

Pack quantity not published.

No case quantity, pack dimension, packed volume or shipped mass is stated for any of the seventeen references.

Manufacturer instructions for use

Shanghai INT Medical Instruments maintains a download area for instructions for use on its product pages. No document for this series was published there at the time of writing, so request the instructions directly from the seller.

The INT-YX-001 series is a procedure pack rather than a device, and that shapes both the case for it and the work of buying it. The case is consolidation: one line item, one reference that encodes both variables, one stock number per configuration and a complete grid with no gaps. The work is that conformity evidence sits in seven documents, and that the sheet publishes six numbers while omitting the ones that decide usability, above all the extension tube pressure rating. Medigear.uk lists the INT-YX-001 series for UK business buyers and can arrange delivery, installation, commissioning, familiarisation and service cover. Request the procedure pack declaration, the component conformity routes, the extension tube pressure rating, and the sterility statement from the seller with the quotation.

FAQ

Frequently Asked Questions

Everything buyers need to know about sourcing medical equipment through MediGear.

It is a procedure pack, and the distinction changes what a buyer has to collect. UK MDR 2002 still gives effect to the earlier directives, under which a combination of CE-marked devices packaged for a specific medical purpose is not itself conformity assessed. The assembler instead draws up a declaration stating that the components bear CE marking, that they have been put together within their stated intended purposes, and that the operation was carried out under appropriate internal control. There is no notified body certificate for the pack. That means the conformity evidence sits in seven places rather than one: the pack declaration, plus the individual route for each of the six components. Ask for all seven.

Not published, and this is the first thing to settle. The sheet gives 30, 60, 90 or 120 cm and no pressure figure, no material and no construction. Interventional angiography and digital subtraction work commonly run connecting lines rated around 900 to 1,200 psi in reinforced or braided construction. Lines supplied for other contrast imaging often run closer to 300 to 350 psi. A line used above its rating can fail without warning through rupture or micro-leaks at peak flow. This datasheet does not say whether these tubes can be used with a power injector at all. Request the pressure rating in psi or MPa, the tube material, and a statement of whether the construction is braided.

The sheet gives a French size and stops there. An introducer set is normally specified by French size, sheath length, and guidewire, and comparable sets are offered with sheath lengths of roughly 7, 11, 15, and 25 cm and guidewires differing in diameter, length, and tip form. None of that appears here, and neither does a dilator description, a wall-thickness statement, nor a hydrophilic-coating statement. Request the sheath length options, the guidewire diameter, length and tip, the dilator detail, and whether the sheath is thin-walled or coated.

That depends on figures the sheet does not give. French size on a sheath denotes the inner diameter, meaning the device size the sheath accepts, and the outer diameter is larger. Published outer diameters for thin-wall radial sheaths run around 2.29 mm at 5F, 2.62 mm at 6F and 2.95 mm at 7F, against a radial artery of roughly 2.9 mm with wide individual variation. In everyday practice, 6F is the working size for radial intervention; 7F is reserved for complex work and is the practical radial limit in many patients; and 8F is generally femoral territory. Since this sheet provides no outer diameter or wall statement, ask the seller for the outer diameter at each French size and confirmation of the intended access route.

Not stated anywhere, which is a striking omission for a pack whose contents enter an artery. Every component here is invasive or contacts the bloodstream, so sterility is not optional. Request the sterilisation method, the validation standard, the packaging standard used for terminally sterilised devices, the shelf life and the expiry format. Ask separately whether the pack is sterilised as an assembled pack or built from individually sterilised components, because separate rules apply where a pack is sterilised under the assembler's own name.

Unclear from the sheet, and it needs an answer before both references are listed. Its published specification is identical to INT-YX-001-01 across all six columns: 5F, 3 ports, 12 mL, 18G, 30 cm, and 15D. A different reference number ordinarily signals a different product, so something differs that this table does not capture. Plausible candidates include a different introducer brand or sheath length, a different guidewire, a different market registration or a packaging change. Ask the seller what separates the two, and do not list both until you have an answer.

The pack contains a Seldinger needle and a scalpel, so it falls under two separate parts of the employer's sharps duty. Regulation 5 of the Health and Safety (Sharp Instruments in Healthcare) Regulations 2013 requires an employer to avoid the use of medical sharps where reasonably practicable and, where it is not, to substitute safer sharps incorporating features that prevent or minimise accidental injury. No safety-engineered feature is published for either item here. That does not disqualify the pack, but it does mean the local risk assessment must record why an unprotected needle and blade were accepted, and that the used sharps leave by a different waste route from the rest of the pack.

The designation is not standard in UK usage and should be confirmed, not assumed. Comparable interventional sets specify a blade by number, and a 15 blade is a small curved blade widely used for the skin nick before sheath insertion. The sheet does not explain what the D denotes, and it may indicate a disposable holder, a supplier code, or something else entirely. Ask for the blade number, whether the item is a complete disposable scalpel or a blade alone, and whether the holder incorporates any blade guard.

CE-marked devices remain accepted in Great Britain under transitional arrangements, currently to 30 June 2028 for devices certified under the earlier EU directive and to 30 June 2030 for devices certified under the EU Medical Device Regulation. The MHRA consulted during 2026 on recognising CE marking indefinitely and then confirmed those routes would not form part of the pre-market legislation expected that year, so both dates stand. Systems and procedure packs must be registered with the MHRA in their own right before reaching the market, and a manufacturer established outside the UK must appoint a UK Responsible Person. Note also that Northern Ireland does not recognise UKCA marking, so a supplier serving all four nations needs both positions covered.

No, and it is worth saying plainly so nobody misfiles it. The procedures these packs support are performed under fluoroscopy, but the duties under the Ionising Radiations Regulations 2017 and the Ionising Radiation (Medical Exposure) Regulations 2017 attach to the employer, the imaging equipment and the people operating it. Nothing in this pack emits radiation or carries a radiation obligation of its own. The kit is a passive consumable and sits outside portable appliance testing and every electrical safety scheme as well.

Any service that cannot obtain the extension tube pressure rating in writing should not order it, because a service using power injection cannot verify compatibility without that number. A radial-first laboratory needs the outer diameter and wall thickness before deciding which of the four sizes it can use, and may find that only part of the range applies. A department that has standardised on a specific guidewire or sheath length will need those specifications confirmed before the pack can displace anything. For a service whose contrast delivery is by hand and whose access practice is femoral, the pack answers a straightforward question about stock consolidation.

Send it as one list. It covers the procedure pack declaration, the component list with each component's manufacturer and conformity route, the extension tube pressure rating with material and construction, the introducer set sheath length and guidewire specification, the sheath outer diameter at each French size, the manifold and syringe pressure ratings, the Seldinger needle length, the scalpel blade number and holder type, the sterility method and shelf life, the connector standard the leakage claim rests on, the difference between the two 5F references, the pack quantity and shipped mass, and the UK Responsible Person with the MHRA registration reference.